Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis

Hyperphosphatemia Clinical Trial

Official title:

A 34-Week Single-Blind Trial of Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897502
• Other study ID #: EMRP-112-047
• Status: Completed
• Phase: N/A
• Start date: July 4, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: E-DA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the improvement degree of nutritional care program on the nutritional status and eating habits of hemodialysis patients

Description:

After being informed about the study and potential risks, all patients giving written Informed consent will undergo a 1-week screening period to determine eligibility For study entry. At week 0, eligible patients will be assigned to the intervention group and the control group by single-blind manner(participant) with convenience sampling. In the intervention group, the patients were trained in The Transtheoretical Model on nutritional education for 8 weeks. In the control group, the patients were trained in roution nutrition education.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 29, 2024
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years and older

Eligibility

Inclusion Criteria:

1. the biochemical value = 5.5 mg/dl or albumin value<3.8g/dL

2. BMI<23kg/m2

3. Unexpected weight loss.

4. Must be able to swallow tablets

Exclusion Criteria:

1. Clinical diagnosis of Alzheimer's Disease

2. Malignant tumors, gastrointestinal cachexia, and catheterization

Related Conditions & MeSH terms

• End-Stage Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• multimedia education
The experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses. The control group use routine education.

Locations

Country	Name	City	State
Taiwan	Liu liu.yin	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Liu, Liu-Yin

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Karavetian M, Elzein H, Rizk R, Jibai R, de Vries N. Nutritional education for management of osteodystrophy: Impact on serum phosphorus, quality of life, and malnutrition. Hemodial Int. 2016 Jul;20(3):432-40. doi: 10.1111/hdi.12405. Epub 2016 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Biochemical value (Albumine) at the third month	Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition	Baseline and the third month
Primary	Change from Baseline in Biochemical value (Albumine) at the fourth month	Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition	Baseline and the fourth month
Primary	Change from Baseline in Biochemical value (Albumine) at the sixth month	Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition	Baseline and the sixth month
Primary	Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month	Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k	Baseline and the third month
Primary	Change from Baseline in Biochemical value( normalized protein catabolic rate) at the fourth month	Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k	Baseline and the fourth month
Primary	Change from Baseline in Biochemical value( normalized protein catabolic rate) at the sixth month	Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k	Baseline and the sitxth month
Primary	Change from Baseline in Biochemical value(cholesterol )at the third month	Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition	Baseline and the third month
Primary	Change from Baseline in Biochemical value(cholesterol )at the fourth month	Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition	Baseline and the fourth month
Primary	Change from Baseline in Biochemical value(cholesterol )at the sixth month	Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition	Baseline and and the sixth month
Primary	Change from Baseline in Biochemical value(creatine)at the third month	Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition	Baseline and the third month
Primary	Change from Baseline in Biochemical value(creatine) at the fourth month	Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition	Baseline and the fourth month
Primary	Change from Baseline in Biochemical value(creatine) at the sixth month	Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition	Baseline and the sixth month
Primary	Change from Baseline in Biochemical value( Phosphate) at the third month	Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL	Baseline and the third month
Primary	Change from Baseline in Biochemical value( Phosphate) at the fourth month	Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL	Baseline and the fourth month
Primary	Change from Baseline in Biochemical value( Phosphate) at the sixth month	Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL	Baseline and the sixth month
Primary	Change from Baseline in body measurement ( Hand grip strength ) at the third month	Hand grip strength is a validated to assess the nutritional status of hemodialysis, male = 30 kilograms, female = 20 kilograms, indicating a risk of frailty	Baseline and the third month
Primary	Change from Baseline in body measurement ( Hand grip strength ) at the fourth month	Hand grip strength is a validated to assess the nutritional status of hemodialysis, male = 30 kilograms, female = 20 kilograms, indicating a risk of frailty	Baseline and the fourth month
Primary	Change from Baseline in body measurement ( Hand grip strength ) at the sixth month	Hand grip strength is a validated to assess the nutritional status of hemodialysis, male = 30 kilograms, female = 20 kilograms, indicating a risk of frailty	Baseline and the sixth month
Primary	Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the third month	(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. =11 points malnutrition risk. =7 points malnutrition.	Baseline and the third month
Primary	Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the fourth month	(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. =11 points malnutrition risk. =7 points malnutrition.	Baseline and the fourth month
Primary	Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the sixth month	(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. =11 points malnutrition risk. =7 points malnutrition.	Baseline and the six month
Secondary	Change from Baseline in the diet of knowledge form at the third month	The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge	Baseline and the third month
Secondary	Change from Baseline in the diet of knowledge form at the fourth month	The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge	Baseline and the fourth month
Secondary	Change from Baseline in the diet of knowledge form at the sixth month	The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge	Baseline and the sixth month
Secondary	Change from Baseline in the diet of attitude form at the third month	The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating	Baseline and the third month
Secondary	Change from Baseline in the diet of attitude form at the fourth month	The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating	Baseline and the fourth month
Secondary	Change from Baseline in the diet of attitude form at the sixth month	The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating	Baseline and the sixth month
Secondary	Change from Baseline in the diet of behavior form at the third month	The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior	Baseline and the third month
Secondary	Change from Baseline in the diet of behavior form at the fourth month	The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior	Baseline and the fourth month
Secondary	Change from Baseline in the diet of behavior form at the sixth month	The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior	Baseline and the sixth month
Secondary	Change from Baseline in the high phosphorus food frequency questionnaire at the third month	The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus.	Baseline and the third month
Secondary	Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month	The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus.	Baseline and the fourth month
Secondary	Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month	The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus.	Baseline and the sixth month
Secondary	Change from Baseline in the six major food frequency questionnaire at the third month	The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies	Baseline and the third month
Secondary	Change from Baseline in the six major food frequency questionnaire at the fourth month	The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies	Baseline and the fourth month
Secondary	Change from Baseline in the six major food frequency questionnaire at the sixth month	The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies	Baseline and the sixth month

External Links

•   I will refer to the food composition analysis in the materials, and the part about phosphorus and protein will be the basis of the research.